Ten medicines recommended for approval, including two orphans

The CHMP recommended granting a marketing authorisation for Jorveza (budesonide) to treat eosinophilic esophagitis, a rare inflammatory condition of the oesophagus. This medicine was reviewed under EMA's accelerated assessment mechanism, reserved for medicines of major public health interest. Jorveza has an orphan designation. For more information, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Prevymis (letermovir), an antiviral medicine that prevents cytomegalovirus reactivation and disease in patients who receive immunosuppressant medicines following an allogeneic haematopoietic stem cell transplant. Prevymis has an orphan designation. For more information on this medicine, please see the press release in the grid below.

The CHMP recommended granting a marketing authorisation for Ocrevus (ocrelizumab), for the treatment of adult patients with relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS). For more information, please see the press release in the grid below.

Adynovi (rurioctocog alfa pegol) received a positive opinion for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A.

The CHMP adopted a positive opinion for Fasenra (benralizumab) for the treatment of severe eosinophilic asthma.

Intrarosa (prasterone) received a positive opinion for the treatment of vulvar and vaginal atrophy in postmenopausal women.

One biosimilar medicine was recommended for approval by the Committee: Mvasi (bevacizumab) for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Three generic medicines received a positive opinion from the CHMP: Darunavir Krka (darunavir) and Darunavir Krka d.d. (darunavir), both for the treatment of human immunodeficiency virus (HIV-1) infection; and Fulvestrant Mylan (fulvestrant), for the treatment of locally advanced or metastatic breast cancer.

The applicants for Fanaptum (iloperidone) and Onzeald (etirinotecan pegol) requested re-examinations of the Committee's negative opinions for these medicines adopted at the July 2017 meeting. After considering the grounds for these requests, the CHMP re-examined the initial opinions and confirmed its previous recommendations to refuse the granting of marketing authorisations for these medicines.

For more information on these negative opinions, please see the questions-and-answers documents in the grid below.

The Committee recommended extensions of indications for Adcetris, Genvoya, Nplate and Orkambi.

Outcome of review on Zinbryta

The CHMP concluded its review of the multiple sclerosis medicine Zinbryta (daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage. For more information please see the public health communication in the grid below.

Withdrawals of applications

Applications for initial marketing authorisations for Kyomarc (bevacizumab) and Plivensia (sirukumab) have been withdrawn.

Kyomarc was intended to be used to treat cancer of the colon or rectum, breast cancer, non-small cell lung cancer, kidney cancer, cervical cancer, and cancer of the ovary, the fallopian tube, or the peritoneum.

Plivensia was intended to be used to treat rheumatoid arthritis.

An application to extend the use of Keytruda (pembrolizumab) in metastatic non-squamous NSCLC in combination with chemotherapy has also been withdrawn.

Questions-and-answers documents on these withdrawals are available in the grid below.

Agenda and minutes

The agenda of the November 2017 meeting is published on EMA's website. Minutes of the October 2017 CHMP meeting will be published in the coming weeks.

Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.